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| FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs |
The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.
The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.
FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.
"We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," said Dr. Janet Woodcock, FDA's chief medical officer and acting director of the agency's Center for Drug Evaluation and Research. "In addition to today's regulatory action, FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies. Women taking these drugs should discuss with their health care providers the drugs' risks and whether they're getting effective treatment."
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FDA Receives New Data on Risks of Anemia Drugs
Consistent With Previous Data on Tumor Growth and Death |
The U.S. Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. The studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn't receive the anemia drug.
These two studies were not among the six studies that were described in revised labeling approved by FDA Nov. 8, 2007, which strengthened warnings about ESAs in cancer patients.
Taken together, all eight studies show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared to patients who did not receive this treatment. In all of these recent studies, ESAs were administered in an attempt to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater, although many patients did not reach that level.
FDA plans to discuss this new data and revisit the risks and benefits of using ESAs in patients with chemotherapy-induced anemia at a public advisory committee meeting in the next few months.
"This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous communications," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.
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| "Swish-and-Spit" Test Accurate for Cancer |
A morning gargle could someday be more than a breath freshener - it could spot head and neck cancer, say scientists at Johns Hopkins. Their new study of a mouth rinse that captures genetic signatures common to the disease holds promise for screening those at high risk, including heavy smokers and alcohol drinkers.
Lead investigator Joseph Califano, M.D., says his group at both Hopkins' Department of Otolaryngology - Head and Neck Surgery and at the Kimmel Cancer Center asked 211 head and neck cancer patients and 527 individuals without cancers of the mouth, larynx or pharynx to brush the inside of their mouths, then rinse and gargle with a salt solution. The researchers collected the rinsed saliva and filtered out cells thought to contain one or more of 21 bits of chemically altered genes common only to head and neck cancers. Tumor and blood samples also were collected.
The cellular mishaps occur when small molecules called methyl groups clamp on to the DNA ladder structure of a gene. In the grip of too many methyl groups, these genes can incorrectly switch on or off in a process called hypermethylation. "Mass-methylation" of particular genes can lead to cancer, the researchers say. Methylation mistakes in other genes could be triggered simply by aging and amount to no more than fine lines and wrinkles.
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Similar Outcomes For Patients With ACS Treated With Different Anticoagulant Regimens
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Patients with acute coronary syndromes such as unstable angina who were undergoing an invasive treatment and received one of three anticoagulant regimens did not have significant differences in the rates of ischemia or death after one year, according to a study in the December 5 issue of JAMA.
"Early angiography followed by interventional or surgical revascularization when appropriate has been shown to result in reduced rates of death, myocardial infarction (MI), refractory ischemia, and rehospitalization in patients with acute coronary syndromes (ACS; unstable angina or non--ST-segment elevation MI [a certain pattern on an electrocardiogram following a heart attack]). Because both MI and hemorrhagic complications have been associated with early and late mortality in patients with ACS and in those undergoing percutaneous coronary intervention (PCI), the optimal [added] pharmacological regimen to support the invasive approach in ACS would ideally suppress adverse ischemic and thrombotic events while minimizing iatrogenic [induced by treatment] bleeding," the authors write.
In the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial, randomization of moderate-risk and high-risk patients with ACS undergoing early invasive management to monotherapy with the direct thrombin (blood-clotting enzyme) inhibitor bivalirudin compared with a heparin-based regimen plus glycoprotein (GP) IIb/IIIa inhibitors resulted in noninferior 30-day rates of adverse ischemic events with reduced rates of major bleeding. The long-term effect of bivalirudin monotherapy and a selective GP IIb/IIIa inhibitor strategy on composite ischemia and death are unknown.
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New Studies Confirm Chest Compressions Alone Are Life-saving for Cardiac Arrest
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For more information or to watch an online demonstration http://www.heart.arizona.edu/publiced/lifesaver.htm Two large-scale studies published in the Dec. 18 issue of the American Heart Association's medical journal, Circulation, report that the chances of surviving cardiac arrest are no better - and may be worse - when bystanders perform mouth-to-mouth breathing than if they press on the chest without interruption.
In part because of the hesitance of bystanders to initiate CPR, survival rates following out-of-hospital cardiac arrest have remained dismal and virtually unchanged despite several changes of the CPR guidelines over the past four decades. In the two latest studies, research groups from Sweden and Japan compared survival rates of cardiac arrest victims after bystanders used either traditional CPR with mouth-to-mouth breathing or Chest-Compression-Only CPR.
Both studies found no statistically significant difference in survival rates. The Swedish study, led by Katarina Bohm, RN, of the South General Hospital in Stockholm, analyzed outcomes of nearly 10,000 cases, while a team led by Taku Iwami, MD, at Japan's National Cardiovascular Center in Suita, Japan, looked at the outcomes of 4,900 cases of witnessed out-of-hospital cardiac arrest. Robert Berg, MD, professor of pediatrics at the UA College of Medicine and a member of the Sarver Heart Center Resuscitation Research Group, co-authored the latter study.
"These independent findings confirm what our Resuscitation Research Group and others have found," says Gordon A. Ewy, MD, director of The University of Arizona Sarver Heart Center, where Continuous-Chest-Compression CPR without mouth-to-mouth breathing was pioneered. "To rescue someone who suddenly collapses for no apparent reason, mouth-to-mouth breathing makes no sense."
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| Big Pharma Spends More On Advertising Than Research And Development |
A new study by two York University researchers estimates the U.S. pharmaceutical industry spends almost twice as much on promotion as it does on research and development, contrary to the industry's claim.
The researchers' estimate is based on the systematic collection of data directly from the industry and doctors during 2004, which shows the U.S. pharmaceutical industry spent 24.4% of the sales dollar on promotion, versus 13.4% for research and development, as a percentage of US domestic sales of US$235.4 billion.
"The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States" is co-authored by PhD candidate Marc-André Gagnon, who led the study with Joel Lexchin, a long-time researcher of pharmaceutical promotion, Toronto physician, and Associate Chair of York's School of Health Policy & Management in the Faculty of Health. Their study appears in the January 3, 2008 issue of PLoS Medicine, an online journal published by the Public Library of Science, at http://medicine.plosjournals.org
"In our paper, we make the case for the need for a new estimate of promotional expenditures by the U.S. pharmaceutical industry," says Gagnon. "We then explain how we used proprietary databases to construct a revised estimate and finally, we compare our results with those from other data sources to argue in favor of changing the priorities of the industry."
The study is important because it provides the most accurate image yet of the promotional workings of the pharmaceutical industry, says Lexchin.
The authors examined the 2004 reports of IMS Health (IMS) and CAM Group (CAM), two international market research companies that provide the pharmaceutical industry with sales/marketing data and consulting services. IMS obtains its data by surveying pharmaceutical firms, while CAM surveys doctors, which explains important discrepancies in the data they provide.
The researchers used 2004 as the comparison year because it was the latest year in which information was available from both organizations.
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| Lack of Vitamin D May Increase Heart Disease Risk |
The same vitamin D deficiency that can result in weak bones now has been associated with an increased risk of cardiovascular disease, Framingham Heart Study researchers report in Circulation: Journal of the American Heart Association.
"Vitamin D deficiency is associated with increased cardiovascular risk, above and beyond established cardiovascular risk factors," said Thomas J. Wang, M.D., assistant professor of medicine at Harvard Medical School in Boston, Mass. "The higher risk associated with vitamin D deficiency was particularly evident among individuals with high blood pressure."
In a study of 1,739 offspring from Framingham Heart Study participants (average age 59, all Caucasian), researchers found that those with blood levels of vitamin D below15 nanograms per milliliter (ng/mL) had twice the risk of a cardiovascular event such as a heart attack, heart failure or stroke in the next five years compared to those with higher levels of vitamin D.
When researchers adjusted for traditional cardiovascular risk factors such as high cholesterol, diabetes and high blood pressure, the risk remained significant with a 62 percent higher risk of a cardiovascular event in participants with low levels of vitamin D compared to those with higher levels.
Researchers observed the highest rate of cardiovascular disease events in subset analyses dividing 688 participants according to high blood pressure status. After researchers adjusted for conventional cardiovascular risk factors, participants with hypertension and a vitamin D deficiency had about two times the risk of having a cardiovascular disease event in five years.
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Believe it or not
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NY doctor's home burns
An obstetrician saved his wife and six children from a fire that ravaged their home, delivered a baby while the house was still smoldering and then got cited with building violations.
Dr. Herman Weiss said Friday "was just my day."
The 37-year-old awoke around 3 a.m. to the screech of a smoke detector and the sight of flames inching up an outside wall of his Long Island home. He got his family to safety, then was paged and went to a hospital to deliver an infant around 6 a.m.
The fire brought scrutiny from building inspectors, who cited the Weisses with a discrepancy in plumbing plans and living in the house without a certificate of occupancy. Weiss said the family had hired a lawyer to get one.
The family has been ordered to tear down the damaged house. Weiss said he hopes to rebuild in the same place. |
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